Director, Regulatory Affairs

Abbott; Lake Forest (IL); On-site; USD 147,000 - 295,000; Full time

Job summary

Abbott seeks a Director of Regulatory Affairs in Lake Forest, IL, to lead compliance efforts and regulatory strategies. This role involves significant influence across product lifecycles, requiring a Bachelor's degree in a related field and 7-10 years of regulatory experience, preferably in medical products.

Benefits

Free medical coverage

Excellent retirement savings plan

Tuition reimbursement

Qualifications

• 7-10 years’ experience in a regulated industry.
• Experience in regulatory affairs preferred.
• Significant experience as a reviewer of diagnostic assays within FDA is preferred.

Responsibilities

• Develop and advance regulatory policies and procedures.
• Conduct regulatory due diligence for new acquisitions.
• Recruit, develop, and mentor regulatory professionals.

Skills

Regulatory Knowledge

Strategic Planning

Leadership

Communication

Education

Bachelor’s degree in science or related field

Advanced Degree - Master’s or Ph.D. preferred

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our location in Lake Forest, IL currently has an opportunity for the Director of Regulatory Affairs.

The function of a Director of Regulatory Affairs is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals.

The individual has division-level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally.

The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, and provide executive management with regulatory metrics/information.

The individual may plan, direct, coordinate, and control the regulatory affairs activities related to products worldwide.

WHAT YOU’LL DO:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Strategic Planning-Identify need for new regulatory policies, processes and SOPs and approve them. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Develop global regulatory strategies and update them based upon regulatory changes.
• Conduct regulatory due diligence for potential and new acquisitions and advise management.
• Set quality and accuracy standards. Anticipate emerging issues and develop solutions to them. Develop solutions to address issues with other members of management and stakeholders. Develop corporate positions on regulatory risk-benefit. Create and develop product positioning strategies based on regulatory requirements. Integrate regulatory considerations into the corporation’s global product entry and exit strategy.
• Recruit, develop, and mentor regulatory professionals.
• Provide guidance for resource and development planning.
• Participate in applicable trade association/industry working groups to influence policy/rule-making in alignment with business strategies

• Pre-market:
  • Communicate application progress to internal stakeholders.
  • Negotiate with regulatory authorities during the development and review process to ensure submission approval.
  • Provide strategic input and technical guidance on regulatory requirements to development teams.
  • Ensure preapproval compliance activities are completed.
  • Formulate company procedures to respond to regulatory authority queries.
• Post-market:
  • Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
  • Ensure a system is in place to manage access to information requests.
  • Provide regulatory input for follow-up to inspections and audits to minimize the potential for findings of noncompliance.
  • Ensure the crisis management program is implemented and functioning. Identify and present options for risk mitigation to decision-makers.
  • Represent regulatory affairs in product recall and recall communication process. Ensure adverse events are reported to regulatory agencies and internal stakeholders.
  • Manage processes involved with maintaining annual licenses, registrations, listings, and patent information.
  • Ensure compliance with product post-marketing approval requirements.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Review and approve publicly disseminated information to minimize regulatory exposure, review product claims, and preserve confidentiality of applicable product information Job specific responsibilities may include (choose applicable areas and expand as appropriate).
  • Medical writing.
  • Advertising and promotion.
  • Labeling.
  • Controlled substances (e.g. DEA).
  • Restricted substances (e.g. REACH).
  • Compendial / standards. Import/export, Country-specific regulatory support.

The scope is division-wide regulatory direction for product development and support to develop the most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies.

Must ensure that all deadlines are met and provide effective leadership without direct authority. Completed work is checked through consultation and agreement with others rather than by formal review of superiors.

Work is performed without appreciable direction and exercises significant latitude in determining technical objectives of assignments; assignments are often self-initiated; determines and pursue courses of action necessary to obtain desired results.

The individual is recognized as a key opinion leader and resource in regulatory affairs.

Influence/Leadership:

Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation.

Provides leadership by communicating and providing guidance toward achieving department, division and/or corporate objectives. Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.

May lead a project team or initiative within a department or cross-functions/divisions.

Provides technical leadership to business units. Acts as a mentor to less-experienced staff internal and external to the department/division.

Exercises judgment independently. Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives. May participate/lead external industry working groups to influence advocacy in alignment with business strategies.

Planning/Organization:

Creates mid- to long-range plans to carry out objectives established by top management.

Develops and calculates a budget for one or more departments to meet organizational goals.

Forecasts future departmental or group needs including human and material resources and capital expenditures.

Determines and establishes organizational structure and supervisory relationships subject to top management approval.

Decision Making/Impact:

Assignments are expressed in the form of objectives.

Work is performed without appreciable direction.

Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.

Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

EDUCATION AND EXPERIENCE YOU’LL BRING:

Education:

Required

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

Preferred:

• Advanced Degree - Master’s degree - In a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is strongly preferred.

Experience:

7-10 years’ experience in a regulated industry (e.g., medical products, nutritional).

7-10 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.

Significant experience as a reviewer of diagnostic assays within FDA CDRH or CBER would be preferred

Background / Skills / Knowledge Regulatory Knowledge of (as applicable):

Regulatory history, guidelines, policies, standards, practices, requirements, and precedents ·

Regulatory agency structure, processes, and key personnel ·

Principles and requirements of applicable product laws ·

Submission/registration types and requirements ·

GxPs (GCPs, GLPs, GMPs) ·

Principles and requirements of promotion, advertising, and labeling

International treaties and regional, national, local, and territorial trade requirements, agreements, and considerations

Domestic and international regulatory guidelines, policies, and regulations

Ethical guidelines of the regulatory profession, clinical research, and regulatory process.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

$147,300.00 – $294,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations DIVISION: CRLB Core Lab LOCATION: United States > Lake Forest : CP01 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf